Comparing telehealth and in-person assessments for glioma patients on oral chemotherapy
Neuro-Oncology Anywhere 242: Pilot Study Evaluating Telehealth and In-Person Assessments in Patients With Glioma Receiving Oral Chemotherapy
This study is testing whether glioma patients on oral chemotherapy are more satisfied with telehealth visits compared to in-person check-ups.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06625047 on ClinicalTrials.gov |
What this trial studies
This phase IV trial evaluates patient satisfaction between telehealth and in-person neuro-oncology assessments for glioma patients receiving oral chemotherapy. The study aims to measure satisfaction through Press-Ganey survey scores and assess the completion rates of chemotherapy, patient preferences, acute care utilization, neurological impairment, and quality of life. By utilizing telehealth, the trial seeks to address barriers that glioma patients may face in accessing high-quality care. The study will involve patients receiving temozolomide, with assessments conducted over a 28-day period following each type of visit.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with glioma requiring adjuvant chemotherapy, specifically those eligible for temozolomide treatment.
Not a fit: Patients who are not diagnosed with glioma or those who do not require chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance access to care and improve patient satisfaction for glioma patients undergoing treatment.
How similar studies have performed: Other studies have shown promising results with telehealth approaches in oncology, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Diagnosis of glioma requiring adjuvant chemotherapy. Patients with glioblastoma (GBM); astrocytoma, IDH-mutant; oligodendroglioma IDH-mutant, 1p/19q codeleted are eligible * Patients eligible to receive temozolomide as standard of care adjuvant therapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, AND Karnofsky performance status (KPS) of ≥ 60 * Expected survival ≥ 6 months in the opinion of treatment team * Willing and able to adhere with the protocol for the duration of the study including undergoing treatment, and attending scheduled visits, and examinations * Participants who do not have devices that will permit telehealth visits will be provided such tablet devices to facilitate appointments for the duration of the study * Participants who do not have financial resources to travel for in-person visits will be provided assistance for cost of travel * Ability to complete patient experience surveys by the participant with or without assistance from their caregiver Exclusion Criteria: * Uncontrolled and/or intercurrent illness or other condition which limits safety of or compliance with study proceedings * Pregnant or nursing, imprisoned, or lacking capacity for understanding * Unable to swallow tablets or at risk for impaired absorption of oral medication * Known hypersensitivity or allergy to temozolomide
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Ugur T. Sener, MD — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.